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Eurneffy (epinephrine) is an alternative to injectable formulations, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization in the European Union for Eurneffy (epinephrine), the…

EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other…

EMA’s human medicines committee (CHMP) has concluded its review of the medicine Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorisation be revoked, because its…

Taking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalized Ratio (INR), and result in severe bruising and bleeding,…

Today, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD)…

Pilots are part of ACT EU collaboration to foster high-quality clinical research in the EU. The Accelerating Clinical Trials in the EU (ACT EU) initiative is today…

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in adults…

EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older…

Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially…

The U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved…

An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients,…

The Product Information (PI) documents for all selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) have been aligned to reflect the…

Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024 meeting-Hydroxyprogesterone caproate medicines to be suspended from the EU market EMA’s safety committee (PRAC) has recommended…

New boxed warnings are being added to the patient information leaflets (PIL) of montelukast due to neuropsychiatric reactions as a result of MHRA review More prominent…

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 May 2024) approved two new formulations of the medicine cabotegravir (Apretude 30 mg film-coated…